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By Jared A. Favole

SILVER SPRING, Md. -(Dow Jones)- A prominent medical expert on Tuesday urged the U.S. Food and Drug Administration to raise its standards for approving diabetes drugs, saying companies need to prove new drugs don't increase cardiovascular disease, the leading killer of diabetics.

Cardiologist Steven Nissen of the Cleveland Clinic said the FDA should require companies to prove their drugs don't raise risks of cardiovascular disease before they are approved.

Nissen said there are already more than enough diabetes drugs on the market that lower blood glucose levels, and now is the time for the FDA to raise its standards.

"Merely lowering blood glucose levels in diabetes is too simplistic," Nissen said. "We must reduce the complications of diabetes, including cardiovascular disease."

Nissen suggested that, in addition to requiring more pre-approval studies, companies should have large, long-term studies in place when a drug is approved to monitor whether the drug increases the risk of cardiovascular disease.

About 75% of all deaths in diabetes patients are a result of cardiovascular disease, and a move to require more pre-approval studies could slow approval and increase the costs of new diabetes drugs.

Companies such as Bristol-Myers Squibb Co. (BMY) and AstraZeneca PLC (AZN) are seeking FDA approval for diabetes drugs, and would be affected by any change in the process.

The FDA is weighing whether to require that new and already-approved diabetes drugs have a positive impact on cardiovascular disease and life span, which are more difficult to measure than current benchmarks such as lower blood sugar. No drug that regulates sugar levels has yet shown beneficial cardiac effects in Type 2 diabetics, who make up more than 90% of all diabetes patients.

A shift away from current research benchmarks, known as surrogate endpoints, might change the entire framework of drug approval because research on most medicines - from anemia to cancer drugs - relies on such interim measures.

About one in 12 Americans now has diabetes, according to the Centers for Disease Control and Prevention. A change in standards could affect companies such as GlaxoSmithKline PLC (GSK) and Takeda Pharmaceutical Co. (4502.TO), which had $4.4 billion and $2.9 billion in diabetes drug sales in 2007, respectively, according to IMS Health, an information consulting firm.

The issue of diabetes drugs standards is part of a two-day meeting starting Tuesday.

The meetings were prompted in part by controversies about research on cholesterol-lowering drug Vytorin and Avandia, a diabetes drug.

In approving the drugs, the FDA relied on surrogate endpoints that, in the case of Glaxo's Avandia, showed the drug helped regulate blood-sugar levels in patients with Type 2 diabetes, in which blood sugar is too high. But a study last year suggested that Avandia patients' life spans didn't improve because their risk for heart attack increased.

Some doctors who specialize in treatment of diabetics emphasized the importance of lowering blood sugar in preventing blindness and other major problems associated with diabetes.

Robert Ratner, who presented at Tuesday's meeting, urged the FDA not to forget about other major side effects of diabetes drugs that are controlled when blood glucose levels are regulated.

Citing Center for Disease Control and Prevention data, Ratner said about 55 diabetics a day become blind.

"I personally don't believe diabetes drugs need to be approved solely on the basis of" a reduction in cardiovascular disease, said Ratner, a vice president at MedStar Research Institute.

Some people questioned suggestions that there are enough diabetes drugs on the market, citing evidence that diabetes drugs lose their effectiveness on people over time.

"As a patient, I don't think we always know how to lower glucose levels," panel member and diabetic Rebecca Killion said. "This kind of approach, while I can see the benefit of it, it will have a chilling effect on development."

Nissen disagreed.

"I don't think it will have a chilling effect but, if we take drugs forward that lower blood sugar but increase the risk of death and heart attack, we haven't done diabetics any favors."

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